GB 15193.9-2003 Dominant lethal test

This standard specifies the basic technical requirements for dominant lethal tests. This standard is applicable to the evaluation of the possible harm to human body caused by the mutagenic effects of chemical, biological and physical factors involved in the production, storage, transportation and sales of food that may cause harm to health (inspecting the damage to chromosome structure and quantity, but not detecting gene mutation and toxic effects). The test objects include food additives (including nutritional enhancers), new food resources and their ingredients, new resource foods, irradiated foods, food containers and packaging materials, food tools, equipment, detergents, disinfectants, pesticide residues, veterinary drug residues, food industry microorganisms, etc. GB 15193.9-2003 Dominant lethal test GB15193.9-2003 standard download decompression password: www.bzxz.net

ICS 07. 100
National Standard of the People's Republic of China
GB15193.9—2003
Replaces GB15193.9—1994
Dominant lethal test
Dominant lethal test
Issued on September 24, 2003
Ministry of Health of the People's Republic of Chinawww.bzxz.net
Standardization Administration of the People's Republic of China
Implemented on May 1, 2004
GB15193.9—2003
The full text of this standard is mandatory.
This standard replaces GB15193.9--1994 "Dominant lethal test". Compared with GB15193.9-1994, this standard has been modified as follows: - In the "Scope", the specific content of the test objects has been added: chemical, biological and physical factors involved in the production, processing, storage, transportation and sales of food that may cause harm to health; the test objects include food additives (including nutritional fortifiers), new food resources and their ingredients, new resource foods, irradiated foods, food containers and packaging materials, food tools, equipment, detergents, disinfectants, pesticide residues, veterinary drug residues, microorganisms used in the food industry, etc.; - In the "Experimental Animals": "Adult mice (weighing more than 30g) or rats (weighing more than 200g)" is changed to "adult mice (sexually mature, weighing more than 30g) or rats (sexually mature, weighing more than 200g)", "Number of animals" male animals per group shall not be less than 10-15, female animals per group shall not be less than 20-30, changed to male animals per group shall not be less than 15, female animals per group shall not be less than 30 pregnant rats;
The two items "Number of groups" and "Number of animals" under "Grouping" are merged into "Dose and grouping", and the design method of high-dose group is added with "When the maximum dose (maximum use concentration and maximum gavage capacity) of the test substance in the acute toxicity test cannot measure LDso, 10g/kg body weight, 100 times the possible intake of humans, or the maximum tolerated dose of the test substance is used as the highest dose"; - Add "Result judgment" content.
From the date of implementation of this standard, GB15193.9-1994 will be abolished at the same time. This standard is proposed and managed by the Ministry of Health of the People's Republic of China. Drafting units of this standard: Tongji Medical University, Shanghai Medical University. The main drafters of this standard are Zhu Qinghua and Liu Qipei. This standard was first issued in 1994 and this is the first revision. 66
1 Scope
Dominant lethal test
This standard specifies the basic technical requirements for dominant lethal test. GB 15193.9—2003
This standard is applicable to the evaluation of the mutagenic effects of chemical, biological and physical factors that may cause harm to health and possible harm to the human body during the production, processing, storage, transportation and sales of food (detecting damage to chromosome structure and quantity, but not gene mutation and toxic effects). The test objects include food additives (including nutritional fortifiers), new food resources and their ingredients, new resource foods, irradiated foods, food containers and packaging materials, food tools, equipment, detergents, disinfectants, pesticide residues, veterinary drug residues, microorganisms used in the food industry, etc.
2 Principle
Mutagens can cause chromosome aberration in mammalian germ cells, so that they cannot combine with opposite-sex germ cells or cause the death of fertilized eggs before implantation, or cause early embryonic death. 3 Experimental animals
Select healthy animals that meet the test specifications and have a certificate number. After the reproductive capacity pre-test, the pregnancy rate should be above 70%. Male adult mice (sexually mature, weighing more than 30g) or rats (sexually mature, weighing more than 200g) are pre-exposed to the test substance before mating. Adult female mice used for mating are not exposed to the test substance. The number of female mice is 5 to 6 times that of male mice. There are generally no less than 15 male mice in each group. Male mice and female mice mate to produce at least 30 pregnant female mice in each group. 4 Dosage and grouping
The test should have at least 3 test substance dose groups. The high-dose group should cause a slight decrease in animal fertility. The dose of each test substance can be between 1/10 and 1/3 LDs. In acute toxicity tests, when the maximum dose (maximum concentration and maximum gavage capacity) of the test substance cannot be used to calculate the LDsc, 10 g/kg body weight, 100 times the possible human intake, or the maximum dose of the test substance is used as the highest dose, and two dose groups are set up, and a solvent control group and a positive control group are also set up. Cyclophosphamide (40 mg/kg body weight) can be used as a positive control. There should be no less than 30 pregnant mice in each group of female animals. Generally, positive and solvent control groups should be made at the same time. 5 Operating steps
5.1 Administration of the test substance
5.1.1 Administration route: gavage or feeding should be used. 5.1.2 Method of administering the test substance: gavage is generally once a day, or twice a day, for 6 consecutive days or 3 months. 5.2 Mating
After the male rats were given the test substance, they were caged together in a ratio of 2:1 for 6 days, and then the female rats were taken out and raised separately. One day later, the male rats were caged together with another batch of female rats of the same number, and this was repeated for a total of 5 to 6 batches. 5.3 Embryo Examination
On the 15th to 17th day from the day when the male and female rats were caged together, the female rats were killed by cervical dislocation, and the uterus was immediately removed from the abdomen. The number of live fetuses, early dead embryos, and late dead embryos of each female rat were carefully examined and counted, and the number of live fetuses, early dead embryos, and late dead embryos of each female rat were recorded separately. 5.4 Embryo Identification
Live fetus: fully formed, bright red in color, with natural movement, and movement response after mechanical stimulation. Early dead embryo: The embryo is small in size, incomplete in appearance, and the placenta is small or not obvious. The earliest dead embryo will bulge on the endometrium like a small tumor. If it has been completely absorbed, only a dark brown dot will be left on the endometrium. Late dead embryo: formed, dull in color, no natural movement, no movement response after mechanical stimulation. 6 Data processing
Conception rate (%)=
Number of pregnant mice
Number of mated female mice
Total number of implantations=
Number of live fetuses/
Number of early embryonic deaths/
Number of late embryonic deaths/Average number of implantations
Early (late) embryonic deaths × 100
Total number of implantations
Average number of early embryonic deaths-
Number of early embryonic deaths
Number of pregnant female mice
Statistical analysis was performed on the above-mentioned indicators of the experimental and control groups using the X2 test, one-way analysis of variance or rank sum test to evaluate the mutagenicity of the test substances. >
Result judgment
Evaluate based on the pregnancy rate, total number of implantations, early and late embryo mortality rates calculated above. When the pregnancy rate or total number of implantations in the experimental group is significantly lower than that in the control group, and the early or late embryo mortality rate is significantly higher than that in the control group, and there is an obvious dose-response relationship and statistical significance, it can be confirmed as a positive result. If the difference is statistically significant but there is no dose-response relationship, the test must be repeated, and the results that can be repeated can be determined as positive. 68
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